MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-26 for TISSUE-TEK PARAFORM BIOPSY CASSETTE 7019 manufactured by Sakura Finetek U.s.a., Inc..
[811179]
Paraform cassette containing pt biopsy was reported as possibly mishandled during processing on autotec device. Cassette was reported as separated from frame during processing and when found did not contain biopsy specimen. Tech support provided assistance with identifying possible areas inside the device for locating cassette/specimen. Service was immediately dispatched to evaluate the event, assist with locating the lost cassette, and service the device if necessary. Users of the device reported to service that they did not know where the "missing" cassette was. No sure if the cassette was found, service performed a thorough examination of the device and did not find any loose cassette. The device was in a ready for use condition. Service ran several test cassettes on the device without errors or failure. Customer then ran regular work load through the device without error or failure. Later, it was reported by customer personnel that the missing cassette was located on the date of the event, but was found to be missing the specimen it contained. Customer reported conducting a thorough search in and around the device, but could not locate the specimen.
Patient Sequence No: 1, Text Type: D, B5
[8032361]
During on-site service call, sakura service tech observed user incorrectly loading paraform assembly (cassette and frame) into autotec delivery magazine. Incorrect loading of paraform assembly to input magazine can result in paraform assembly separation during processing by the autotec.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2083544-2008-00001 |
| MDR Report Key | 1024176 |
| Report Source | 05 |
| Date Received | 2008-03-26 |
| Date of Report | 2008-02-22 |
| Date of Event | 2008-02-22 |
| Date Mfgr Received | 2008-02-22 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2009-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HOWARD CHILDERS |
| Manufacturer Street | 1750 WEST 214TH ST. |
| Manufacturer City | TORRANCE CA 90501 |
| Manufacturer Country | US |
| Manufacturer Postal | 90501 |
| Manufacturer Phone | 3107835076 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISSUE-TEK PARAFORM BIOPSY CASSETTE |
| Generic Name | IDZ, IDW |
| Product Code | IDZ |
| Date Received | 2008-03-26 |
| Model Number | 7019 |
| Catalog Number | 7019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAKURA FINETEK U.S.A., INC. |
| Manufacturer Address | TORRANCE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-26 |